Regulatory PathRegulatory requirements compared

Active substance

Vonoprazan

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
VOQUEZNAEQ 10MG BASE; EQ 20MG BASEtablet · oralPHATHOMPrescription1 Nov 2023
VOQUEZNAEQ 10MG BASE; EQ 20MG BASEtablet · oralPHATHOM PHARMACEUTICALS INCPrescription17 Jul 2024

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACVOQUEZNA 10 MG TABLET$22.39663per EA23 Sep 2026
US NADACVOQUEZNA 20 MG TABLET$22.4121per EA23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

  • US FDA 6 Nov 2025 VOQUEZNA — safety-related labeling change
    Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 31 Oct 2025 VOQUEZNA DUAL PAK — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 31 Oct 2025 VOQUEZNA TRIPLE PAK — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for vonoprazan →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.